Drugs

Sen. Paul Introduces Biosimilars Bill

U.S. senator Rand Paul (R-KY) has introduced legislation to streamline the approval process for biosimilars by “eliminating costly and redundant clinical study requirements.” The Expedited Access to Biosimilars Act is intended to “increase market competition, lower drug prices, and increase access to more life-saving treatments,” Paul says in a release. “For too long, the FDA has forced companies to jump through bureaucratic hoops and produce redundant clinical studies that offer no new meaningful scientific information for the approval process. My bill puts an end to wasteful and repetitive clinical requirements that create unjustified barriers, further delaying competition in the market.” The legislation will:

Retain FDA’s requirement for pharmacokinetic studies, and eliminate a blanket requirement of immunogenicity, pharmacodynamics, and clinical efficacy requirements unless scientifically warranted.
Require the agency to justify any additional study requirements.
Accelerate market entrance and competition for biosimilars that are priced lower than brand-name products.

To view the bill, click here.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome